Update: The following update relating to this announcement has been issued:

May 21, 2010 - See Notice NOT-TW-10-457 Notice of Intent to Publish a New Funding Opportunity that will Reconfigure and Consolidate The Millennium Promise Awards: Non-communicable Chronic Diseases Research Training Program (NCoD).

March 23, 2010 - See Notice NOT-OD-10-069 This notice terminates the Institutional Research Training and Institutional Research Career Development Programs listed below because they provide application instructions for paper submissions using the PHS 398 forms.

This research training program is
designed to build research capacity in low- and middle-income countries (LMICs)
in the fields related to cancer, cerebrovascular disease including stroke, lung
disease including chronic obstructive pulmonary disease (COPD) and
environmental factors including indoor air pollution, and obesity and lifestyle
factors related to these conditions as well as genetics of non-communicable
diseases. The institutions applying can be domestic or foreign, but have to
exhibit the ability to do such training, and must exhibit that they have
existing research programs in these fields.

Purpose. This is a Funding Opportunity
Announcement (FOA) for a research training program related to chronic,
non-communicable diseases to help build capacity for research in LMICs,
so-called “developing countries” as defined by the World Bank,
(http://www.worldbank.org/data/countryclass/classgroups.htm).

Mechanism of Support. This FOA will utilize the D43 grant mechanism.

Funds Available and Anticipated Number of
Awards. It is anticipated that $1,500,000 will be
available for this initiative for up to 7 awards per year and up to two
planning grants. Facilities and administrative costs are limited to 8%
for all awards and sub-awards. The earliest anticipated start date
for awards is
July, 2009.

Budget and Project Period. For this
funding opportunity, budgets up to $220,000 total direct costs per
year and time periods up to five years may be requested

Eligible Project Directors/Principal
Investigators (PDs/PIs). Individuals with the skills, knowledge, and
resources necessary to carry out the proposed research training programs are invited to work
with their institution/organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH
support.

Number of PDs/PIs. More than one
PD/PI, or multiple PDs/PIs, may be designated on the application.

Number of Applications.Only one
application per institution(defined by
Institutional Profile File number) is allowed per year. Multiple
schools that are part of one institution should combine their efforts.

Resubmissions. Resubmissions
are acceptable. Such applications must include an introduction addressing
the previous peer review critique (Summary Statement).

This is a funding opportunity announcement for a research
training program related to chronic, non-communicable diseases to help build
capacity for future local research in LMICs. This responds to a number of
goals in the new FIC strategic plan (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm).

The research areas include cancer, cerebrovascular disease including
stroke, lung disease including chronic obstructive pulmonary disease (COPD),
obesity as well as genetics, environmental factors including indoor air
pollution, and lifestyle factors related to these conditions. The research that these trainees would be associated with
is expected to be of importance in the participating LMICs.

Burden of Disease

Chronic non-communicable diseases are steadily increasing
around the world and in LMICs, which will soon account for more than 50% of the
expenditures for health care and more than 50% of the disability adjusted life
years (DALYs). According to the Disease Control Priorities Project and
World Health Organization (WHO), 44% of adult disease burden in LMICs is now
attributable to non-communicable diseases and is projected to increase to 54%
by 2030. The proposed “Grand Challenges in Chronic Non-Communicable
Diseases,” developed through an extensive international consensus process,
clearly shows the imperative to address these problems now. (Daar AS, et al., Nature,
450 (22 Nov 2007): 494-496.) As the origin of and potential solutions
to most chronic diseases are complex in nature, programs that strive to develop
and provide training across disciplines (e.g., bridging biological, social, and
behavioral sciences) are strongly encouraged.

In addition to generating evidence to prevent and treat
chronic diseases, it is imperative that the research findings be incorporated into community
practice in an efficient and timely manner. In fact, we face a formidable
gap between innovations in health (including vaccines, drug discovery and
strategies for care) and their delivery to communities in LMICs (Madon T, Hofman KJ, Kupfer L, Glass RI. Public Health.
Implementation Science. Science.
2007 Dec 14;318(5857):1728-9). Training researchers in the
nascent field of implementation and dissemination science would be appropriate
under this announcement.

Risk factors for chronic non-communicable disease are complex. Many of the key important risk factors are the social
determinants like physical inactivity, poor diet, tobacco smoking and factors
which lead to obesity.

However, the interactions between genetic and environmental risk
factors are critical in the ontogeny of many non-communicable diseases.

Furthermore, it is critical to develop a deeper understanding of the
complex motivations that contribute to risky behavior in a resource poor
setting. These factors can have a profound effect on how risk factors are
perceived and incorporated into people’s decision making processes and
ultimately their behavior.

According to WHO’s estimation, death from stroke each year in
LMICs accounted for more than 85% of stroke death world-wide. The number of
DALYs caused by stroke in LMICs was also seven times higher than the number in
high-income countries (HICs). The
National Institute of Neurological Disorders and Stroke (NINDS) is interested
in supporting research training in mechanistic, epidemiological, prevention,
translational and clinical research in the areas of stroke.

Lung disease due to cigarette smoke (direct or indirect) or
especially indoor air pollution at work or at home is rapidly increasing in
both adults and children. WHO estimates by 2030, COPD will be among the four leading
causes of death globally (http://www.who.int/whosis/whostat2007_10highlights.pdf). According to WHO estimates, 210 million people
currently have COPD, more than 3 million people died of COPD in 2005,
corresponding to 5% of all deaths globally, and almost 90% of COPD deaths occur
in LMICs (http://www.who.int/mediacentre/factsheets/fs315/en/).

Obesity is becoming a major component of the healthcare
landscape in developing countries, even in countries where under nutrition is
simultaneously present sometime even in the same family. According to WHO, 2.3
billion adults (age = 15 years) will be overweight and 700 million will
be obese worldwide by 2015. In 2005, over 20 million children (< 5
years) were overweight globally. Overweight and obesity are risk factors
for many chronic diseases that affect the quality of life and lead to premature
mortality. Obesity, can for example, lead to hypertension, Type II diabetes,
osteoarthritis, stroke, gall bladder disease, cancer
and coronary artery disease.

Cancer
is becoming more common, due at least in part to aging populations. More than
70% of all cancer deaths occur in LMICs, where resources available for
prevention, diagnosis and treatment of cancer are limited or nonexistent.
Based on projections, cancer deaths will continue to rise with an estimated 9
million people dying from cancer in 2015, and 11.4 million dying from cancer in
2030 (http://www.who.int/cancer/en/).

The bulk of factors that are responsible for onset of the chronic
disease are so diverse that it is essential that those trained in these areas
of research have broad understanding or work across disciplines
that might include nutrition, business and the corporate sector, behavioral
health, health law, economics, environmental health and urban planning. Most of
the research training and research on chronic diseases has been conducted in
HICs and it has seldom been multidisciplinary. This program is therefore intended
to strengthen research capacity by developing a pipeline of scientists in LMICs
who will conduct transdisciplinary and implementation research in this field.

In order to develop the research capacity to carry
out scientific research on these and other topics related to chronic,
non-communicable diseases, the Fogarty International Center has developed this
particular FOA for this research training program.

The objectives of the research training program for
chronic non-communicable diseases are: 1) To train a cadre of experts who
can assess the magnitude of diseases such as cancer, cerebrovascular
disease including stroke, lung disease including chronic obstructive
pulmonary disease (COPD), and obesity as well as genetics, environmental
factors including indoor air pollution, and lifestyle factors related to
these conditions in LMICs; 2) To support training-related research
projects (degree-related or mentored research) that address issues of
importance to chronic disease, directly relevant to the needs of the
people in the foreign country, and are culturally sensitive; 3) To
strengthen the research training capacity and institutional infrastructure
required for success by building on existing research programs on chronic
diseases at the foreign sites; 4) To develop methods to monitor and
understand the etiology of chronic non-communicable disease; 5) To
train researchers who perform research in chronic non-communicable
diseases across a broad range of research areas from genetics to epidemiology
to clinical research to implementation science; 6) To train researchers
who can identify economic factors that influence chronic disease risks,
and who can develop evidence regarding the impact of chronic
non-communicable diseases on families and communities; and 7) To train
individuals who can translate research into public health policy and into
programs of care.

Each research training program application could incorporate an
appropriate mix of long-, intermediate- and short-term training opportunities in a wide
range of relevant disciplines and skills necessary to advance the study of
chronic diseases. It is expected that the proposed training would
strengthen sustainable research and core research support capacity at the
foreign site and could include advanced in-country research at the end of
training. Training may take place at the U.S. or foreign sites and
training-related research should be carried out mainly in the country of the
foreign institution(s). Training is encouraged to take place at the
foreign site. While a range of short-, intermediate- and long-term training is
allowable, emphasis will be on intermediate- to longer-term training, including
mid-career training. In the context of this FOA, “trainees”
are scientists from the LMIC country identified in the application.

The following
types of training could be included:

Long-term (greater than 6 months and up to four years,
depending on resources) training for the full range of skills necessary to
support research and research administration in masters or doctoral
programs, with the understanding that the focus of thesis-related work
will be in the home country of the trainee.

Intermediate-term (three to 6 months) training or
mentoring, including specialized clinical, laboratory, research or
administrative/business skills necessary to support clinical, operational,
health services and implementation science research that is planned or
ongoing.

Short-term (less than three months) training or
mentoring that focuses on research methodology, laboratory skills, ethics
and compliance issues, program and grants administration, accounting,
financial management, grant writing, peer review, preparation of
scientific manuscripts, data management, Internet connectivity, technology
transfer, and medical informatics. This might also include intensive
English language training and other preparation prior to study in the U.S.

Advanced in-country mentored research undertaken by
the trainee in his/her home country upon completion of his/her initial
period of training under the program (masters, Ph.D., post-doctoral or
other significant training).

Additional institutional capacity-building efforts are
strongly encouraged. These may include, but are not limited to,
in-country training workshops in advanced research techniques,
particularly aimed at a wider audience through the use of satellite and
other electronic communication technology, remote learning, interaction
with other national and regional population research and communication
efforts.

Scientific research training for clinicians and health
care professionals including physicians, nurses, dentists and other
practitioners.

When a specific scientific course is given by one training program, it
is expected and encouraged that this course be widely publicized and open to
trainees of the other grantee institutions under this program.

This research training program strongly
encourages principal investigators (PIs) to include women and individuals from
underrepresented racial, ethnic or socially disadvantaged groups in the
LMICs as trainees and faculty at all sites.

LMIC institutions in collaboration with a HIC institution may apply
for a two-year planning grants to support the development and submission of
research training program proposals in the subsequent year.

See Section III.3 “Other Special
Eligibility Criteria” for additional details.

This
funding opportunity announcement (FOA) will use the D43 research training program award mechanism. The Project Director/Principal Investigator (PD/PI) will be
solely responsible for planning, directing, and executing the proposed project.

This program does not use the Modular budget format.
You must include detailed budget information.

It is anticipated that approximately
$1,500,000 will be available per year for this program utilizing funds
from FIC and co-sponsoring organizations.

It is anticipated that approximately
7 new awards per year will be made and 1 to 2 2-year planning grants per
year, subject to availability of funds.

The expected amount for individual
awards will be up to $220,000 per year (total costs) for up to 5 years, or $27,000 (total cost) per year for up to two
years for the planning grants.

Awards are anticipated to begin in July,
2009.

The estimated amount of funds available for support of 7 full awards and one to two planning grants initially awarded
as a result of this announcement is $1,500,000
for FY 2009.Future year amounts will
depend on annual appropriations.

Planning Grants for Developing Country
Institutions:

LMIC institutions in collaboration with a HIC institution
may apply for a two-year planning grant to
develop a future chronic disease research training program with U.S. collaborators. Planning grants should propose the following types of activities to
organize and plan for a research-training program, and prepare and assemble an
application to submit for support of that program the following year:

Consultation with U.S. and developing country faculty to:

Assess the specific needs for chronic disease research
training at the developing country institution;

Define the short- and long-term training components to
address the specific needs for chronic disease research training at the
developing country institution in a stepwise plan; and

Define their roles and institutional commitments in the
research-training program.

Targeted training of developing
country faculty to fill gaps in expertise directly related to their role
in the proposed program or in responsible conduct of research, human
subjects education and other research administration areas.

Training ethical review committee
members of developing country institutions to obtain certification related
to the U.S. Federal-Wide Assurance for the developing country institution.

Planning grant program director
training in grant writing.

Because
the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs is the responsibility of the investigators and applicant organizations,
and should be determined by the scientific goals of the project. Applications
for grants with multiple PDs/PIs will require additional information, as
outlined in the instructions below. The NIH review criteria for approach,
investigators, and environment have been modified to accommodate applications
involving either a single PD/PI or multiple PDs/PIs. When considering multiple
PDs/PIs, please be aware that the structure and governance of the PD/PI
leadership team as well as the knowledge, skills and experience of the
individual PDs/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share
the authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttp://grants.nih.gov/grants/multi_pi.

For applications from HICs collaborating with LMICs, the
use of the multiple PI/PD initiative is encouraged with the major foreign
collaboration in each country.

The U.S. PI or the foreign PI applicant should have a doctoral-level
degree. If they do not possess a doctoral-level degree, an explanation
for an exception must be provided in the application.

The applicant must have strong chronic non-communicable disease
research and research-training program experience, and the requisite faculty
and facilities to carry out the proposed research training activities.
The PI and/or key personnel listed on the application must be designated
as the PI of at least one active (with at least 18 months of support remaining
at the time of application) chronic, non-communicable disease-related research
award, directly relevant to the research training proposed and, within 2 years
of the award from this program, at least a portion of that research must be
performed at the foreign site. The research grants may be funded by the
NIH or by other national or international organizations or foundations.
The applicant must have ongoing research in the area of science described
in the application and some existing collaboration with the foreign site which
can be of an educational nature.

The PIs must hold faculty or other long-term research positions at a
public or private non-profit research institution that will allow them adequate
time and provide appropriate facilities, salary support and resources,
including access to patients or patient data, when necessary. Priority will be given to applicants
associated with NIH-funded direct research grants to the foreign institution(s)
or with NIH-funded research grants with foreign components at the foreign
institution(s). Women and individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are encouraged to apply for this program.

Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.

Every effort should be made to comply with the
format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up to 8% Facilities and Administrative
(F&A) costs (excluding equipment) may be requested. SeeNOT-OD-01-028, March 29, 2001.

Organizations must comply with Federal/NIH
policies on human subjects, animals, and biohazards.

Organizations must comply with Federal/NIH
biosafety and biosecurity regulations. See Section
VI.2., “Administrative and National
Policy Requirements”

Proposed research should provide special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not
readily available in the United States or that augment existing U.S. resources.

Applications
with Multiple PDs/PIs

When multiple PD/PIs are
proposed, use the Face Page-Continued page to provide items 3a – 3h for
all PD/PIs. NIH requires one PD/PI be designated as the “contact
PD/PI” for all communications between the PD/PIs and the agency. The
contact PD/PI must meet all eligibility requirements for PD/PI status in the
same way as other PD/PIs, but has no special roles or responsibilities within
the project team beyond those mentioned above. The contact PD/PI may be changed
during the project period. The contact PD/PI should be listed in block 3 of
Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page
1-Continued. When inserting the name of the PD/PI in the header of each
application page, use the name of the “Contact PD/PI, et. al.” The
contact PD/PI must be from the applicant organization if PD/PIs are from more
than one institution.

All individuals designated
as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI
role in that system (other roles such as SO or IAR will not give the PD/PI the
appropriate access to the application records). Each PD/PI must include their
respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing
Multiple PDs/PIs will be required to include a new section describing the
leadership plan approach for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled “Multiple PD/PI Leadership
Plan” must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of the
leadership team and the research project should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.

Prospective applicants
are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research training

Name, address, and telephone number of the PD/PI(s)

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.

Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three
signed photocopies in one package to:

Applications must be received on or before the application
receipt/ date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review.

Upon receipt applications will be evaluated for
completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial merit review unless the applicant withdraws the pending application.
The NIH will not accept any application that is essentially the same as one
already reviewed. However, the NIH will accept a resubmission application, but
such application must include an Introduction addressing the critique from the
previous review.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

Detailed
Budget for Initial Budget Period

Use the following instructions for preparing Budget:

Develop a budget that reflects the resources necessary to implement
the components of the comprehensive research-training plan included in your
application. The budgets may include costs to support the various types
of research training proposed for trainees (tuition/fees, stipends, and travel)
and faculty (salary, per diem costs at the foreign site), and costs to support
the administration of the program.

Provide a detailed budget justification explaining how requested funds
will primarily support LMIC trainees. LMICs are defined through the World Bank
website and can be found at http://www.worldbank.org/data/countryclass/classgroups.htm).
All expenses related to trainee participation in the program should be itemized
on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate
categories. All expenses related to faculty participation in the program
should be itemized on the PHS Form 398 (budget form pages 4 & 5) in the
appropriate categories. The total direct costs of the trainee
participation budget should be identified on PHS Form 398 (budget form pages 4
& 5) in the "Other" category. The combining of the budget
figures will allow reviewers and FIC staff to review a composite budget of all
costs.

Faculty Participation (budget form page 4)

Requested Salary Support: The salary for the PI,
other training faculty and administrative staff must be commensurate with the
salary structure and benefits at the institution where they are employed and
within the limits described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html.
Foreign collaborators may receive appropriate compensation for their significant
activities on the program, such as recruitment and selection activities, as
well as other program-related roles. The administrative, training or
teaching responsibilities and time commitment for personnel receiving salary
should be thoroughly described and justified. The salary and fringe
benefits for the PIs and staff in total should not exceed 30 percent of total
direct costs.

Faculty Travel: Funds may be requested for
round-trip economy airfare on U.S. carriers (to the maximum extent possible) and
lodging and per diem for U.S. faculty providing training at the foreign site.

Network Meetings: There will be an annual program
network meeting to coordinate program activities, normally in the U.S., for which the applicant should budget. Principal Investigators are expected to
attend. Applicants may also budget for grant administrators, other
faculty, collaborators and trainees to attend. The attendance of trainees
is particularly encouraged.

Trainee Participation (NRSA substitute budget form page 4)

Trainee Stipends: Trainees may be paid a stipend
comparable to their professional experience in accordance with NRSA levels or
grantee institutional policies while involved in medium- or long-term training
at the grantee institution. Current NRSA stipend levels may be used as a
guide and are described at http://grants.nih.gov/training/nrsa.htm.

Note that health insurance is not included as part of this budget
category. See the Training Related Expenses category below.

Funds for tuition and academic fees at the U.S. or foreign institution
may be requested. Programs are encouraged to seek cost-sharing
arrangements with the grantee institutions in order to provide reduced tuition
for trainees.

Trainee Travel: Funds may be requested for
round-trip economy class airfare on U.S. carriers (to the maximum extent
possible). Funds may be requested for lodging and per diem for short-term
trainees.

Training Related Expenses: Funds may be requested for
one-time advanced in-country research support of up to $15,000 total costs for
mentored research to be undertaken by a long-term trainee in his/her country
upon completion of their training. Applicants are encouraged to budget
for adequate professional development (including, but not limited to,
international scientific conference attendance) opportunities for
trainees. Training-related expenses (books, computers, and courses for
software, English language proficiency, etc.) may be included but must be
described in the budget justification. Funds for self-only or family
medical insurance may be requested, as long as the same insurance allowance is
provided to other individuals in similar training positions at the sponsoring
institution.

Tuition
and Fees: Funds for tuition and academic fees at
the U.S. or foreign institution may be requested. Programs are encouraged
to seek cost-sharing arrangements with the grantee institutions in order to
provide reduced tuition for trainees.

Budget for Entire Proposed Period of Support

Use the Institutional Training Grant Substitute Form Page 5 for the
trainee expenses and PHS Form 398 Budget form page 5 for administrative and
faculty expenses and for the aggregated total direct costs for the trainee
expenses.

Biographical Sketch

Include biographical sketches for the Program Director(s) and Other
Senior/key Personnel contributing to the training program. This will include
“Collaborators” and Training Advisory Group (TAG) members. Do not
include bio-sketches for mentors as they are attached at 8.9.13 as
Participating Faculty

All Program Director(s) must be registered in the eRA Commons and must
include the assigned Commons User ID. Collaborators and key personnel
should also be registered in the eRA Commons if they are to review
correspondence and comments.

Resources

Resources pages should be completed for all performance sites.
Pertinent research resources and the educational environment including the
options, if relevant, available for distance learning for the proposed
training at the U.S. and partner country institutions should be
described. Creative and innovative use of Information Technology related
to the disease study and/or prevention is encouraged.

An unsuccessful application may only be re-submitted in response to a
FOA for this chronic, non-communicable research training Program.

Note: Twenty-five page limit for Sections 8.9.2-8.9.5

Follow these directions for Sections 8.9.2-8.9.4:

Section 8.9.2 Background

The proposed research-training program may focus on one or more
chronic disease and the associated life-style behavior-impacted diseases (e.g.
oncologic, pulmonary diseases) of major health importance to the population in
the proposed LMIC(s).

The research training should be developed related to a need in the
LMIC institutions. Explain the relevance of the chronic disease focus of
the proposed training to the health of the host country and to the overall
institutional development plan of the foreign site(s).

Describe the background of the research and training collaborations
between the key personnel at the applicant institution(s) and the proposed
partner institution(s).

Identify areas of mutual interest between LMIC institutions and any
co-sponsoring NIH Institutes, Centers or Offices identified on the FOA.

Do not complete Tables 1 and 3. See 8.9.3 Program faculty for
instructions for Table 2 Participating Faculty Members.

A. Program Administration. Describe the
PD/PI’s qualifications for providing leadership of the program, including
relevant scientific background, current research areas, and experience in
research training. Indicate the Program Director's percent effort in the
proposed program.

Describe the administrative structure of the program and the
distribution of responsibilities within it, including the means by which the
program director will obtain continuing advice with respect to the operation of
the program.

If more than one foreign site will participate in the program, provide
a justification for the inclusion of multiple sites within the framework of
budget constraints and the goal of developing institutional research capacity,
for example because the number of available qualified trainees may be
insufficient at one institution or to integrate training across a network
linked through a multi-site research activity. Multiple foreign sites may
also be required to collectively provide the necessary faculty expertise or
infrastructure for a quality, comprehensive research training program in a
particular chronic disease area.

Describe how the proposed research training and capacity building
supports the research priorities of the country of the foreign institution.
Include a description of the procedures to assure this takes place within the
context of the collaborative relationship, including input from scientific and
community advisory boards in the foreign country.

This program cannot be used as the primary support for clinical trials
but could be used to fund training programs related to such clinical trials
provided appropriate safeguards including Federal Wide Assurances,
Institutional Review Boards or International Ethics Committees are duly constituted,
and Data and Safety Monitoring Boards (DSMBs) are in place.

Training Advisory Group (TAG): Describe
the composition and expertise of a TAG composed of expert faculty from the U.S. and the proposed LMICs who are not directly involved in mentoring trainees. The TAG
assists in trainee selection, scientific peer review of trainee projects, and
evaluation of trainees and training program progress.

Describe in detail the internal peer review process that will be used
for training-related and advanced in-country research.

B.Program Faculty.

Describe the roles, responsibilities and commitments from the
senior/key personnel from the U.S. and partner country institution(s). State
what these individuals would actually do and their time commitments to the
program.

Include a list of the other potential mentors and their scientific
areas of interest at the applicant institutions in Table 2 and include
bio-sketches in 8.9.13. Include a summary of the training and mentoring
experience of the faculty in training pre-doctoral and post-doctoral trainees
particularly trainees from LMI countries, with special mention of trainees from
the country focus of the proposed program.

Include letters from senior/key personnel and participating faculty
defining their specific roles (such as mentoring and teaching) and time
commitments in the proposed training program in 8.9.15.

In Table 4, include a list of the research grants in which the PD/PIs,
key faculty at the foreign institution or relevant faculty at the partner
institution have played a key role. Please include source of support and grant
number (if applicable), grant title, project period and current year direct
costs. Include PI if not the faculty member and role played by faculty member
with Grant Title. Include Institution with faculty member name.

Provide a short description of the funded research in Table 4 and any
other currently funded and future research that will serve as the research base
for the proposed research-training program.

Do not complete Table 5

C. Proposed Training.

Use these instructions for the Section C. Proposed Training.

Describe the proposed research training program, including the goals,
objectives and plan for meeting the objectives for this PA. A description
of the plans for the integration of research capacity building activities at
the LMIC institution(s) should be included.

Describe how resources from this award will be integrated with other
research or research training resources at the LMIC institution(s) or within
the LMIC’s to achieve the overall goals of this program: building
sustainable research capacity at the LMIC institution(s).

Describe plans for dissemination of training materials, as well as
other coordination efforts, to other FIC research training programs in LMICs.

Describe how the proposed research training program may serve as a
bridge among academic research, policy makers and public health communities to
help to link the various research areas with the programs supported in the
country by NIH and other sponsors.

Describe an appropriate balance of research training options
(degree-related and non-degree training) to match the needs of the trainees
and their LMIC institution. Long-term (> 6 months) research training may
include studies leading to an advanced degree or a mentored post-advanced
degree experience. Short-term training involving short courses, workshops or
practical experience of up to several months in specific research methods or
other laboratory, clinical, epidemiological, preventive care,
transdisciplinary, social science or field skills for research may be proposed
in addition to long-term training. Participants in short-term training must be
involved in research in which the training will be immediately utilized at
partner country institution(s). Didactic short courses or workshops on broad
scientific or medical topics not directly relevant to the research training
focus of the program will not be supported.

Training and trainee degrees may be attained at either the U.S. or foreign country institution. However, applicants are strongly encouraged to provide
support and mentoring by U.S. and partner country faculty for trainees to
conduct the research related to their training in the partner country to the
greatest extent possible.

Mentored trainee research may focus on basic sciences to understanding
mechanism of diseases, behavior or pathology or to develop new interventions,
prevention measures or diagnostic methods, as well as clinical, operational,
health services and implementation science studies. Trainee research projects
may be part of a training faculty member's peer-reviewed research grant funded
by NIH or other research support agencies.

All training-related research projects in which trainees are involved
under this award must be independently peer-reviewed through scientific review
procedures established by the applicant institution, and have written evidence
of documentation of education in the protection of human subjects for the
trainee (see 8.9.5), compliance with the required federal citations, and
approval from an institutional (or ethical) review board or committee at both
the U.S. and foreign institutions and from the relevant government
authority. Please see: Procedures for Registering Institutional
Review Boards and Filing Federal-Wide Assurances of Protection for Human
Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

Applicants should also provide training in adjunct skills needed at
the partner country institution(s) to support sustainable independent research
such as the use of scientific literature, scientific writing and presentation,
grant writing, bioinformatics, bioethics, good clinical practice, biosafety,
data management, research administration, the management of intellectual
property and English as a second language, if necessary.

Describe plans to include education in the inclusion of children,
women and individuals from underrepresented racial, ethnic and disenfranchised
groups in research in their country. Where appropriate, the design of
training-related research projects should take into account potential sex and
gender differences that may affect the questions asked and the analyses performed.
These might include different responses to and impacts of health interventions,
differences in physiology, and different behavioral bases for disease
prevention strategies.

Applicants are required to provide all long-term trainees
with training in the responsible conduct of research at either the U.S. or developing country institution. For more information on this provision, see the NIH
Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html).
NIH does not require a specific curriculum or format for instruction but the
following areas should be included: conflict of interest, responsible
authorship and institutional policies for handling scientific misconduct, human
subjects, animal studies, data management and data sharing. The inclusion of
international perspectives on these topics is strongly encouraged. The
following information must be provided in the description of your plan: topics
to be covered, format, faculty participating, instructional materials,
frequency and duration of training, and how trainee attendance will be
monitored.

D. Training Program Evaluation.

Awardees will be required to track and document the long-term impact
of this training program on the research capacity of the foreign institution(s)
including the impact on the career of the trainees.

Describe a plan for self-evaluation of the program. Once it is
available, all grantees will be required to use Careertrac, provided by FIC, to
track long- and medium- term trainees during and after their training. To
determine the impact of training on their subsequent careers, grantees are
encouraged to use this tool to continue to track these students for at least
five years after completion of their training. Until the tool is
available, grantees will be required to keep track of their trainees through
training and five years after using their own systems.

Success of the trainees can be measured by the number and quality of
publications, presentations, courses developed, professional awards, grant
funding, career advancement and subsequent employment that demonstrates their
sustained commitment to research careers in their home countries; their contributions
to future international research collaborations and research training; their
influence on the development and use of research findings in their countries;
and their ability to act as consultants, teachers, collaborators and role
models to other local investigators and further disseminate the lessons
learned.

Evaluation metrics should eventually encompass both the success of the
individual trainees and the impact of the program on research capacity at the
foreign institution(s). An evaluation of the impact of training supported
by the grant will be considered an important criterion during any
re-competition of this PA. Applicants should establish some benchmarks
and a mechanism to periodically review the progress of the trainees and the effectiveness
of the program. This may consist of regular meetings among faculty
participating in the program and periodic review by the TAG and other outside
consultants.

E. Trainee Candidates.

Describe recruitment plans, including the sources and availability of
trainees; the qualifications of prospective trainees; and the criteria and
procedures by which trainees will be selected.

Use these instructions for Section E. Trainee Candidates

Training plans should also describe in detail each of the following
processes:

Trainee recruitment;

Trainee candidate evaluation and criteria for
selection;

Pre-training orientation;

Trainee mentorship;

Trainee evaluation;

Post-training integration into the collaborating
developing country institution's chronic disease research activities; and

Dissemination of trainee research results to the
relevant international scientific community and the clinical or public
health sectors of the developing country

Describe the characteristics of the trainees you plan to recruit for
each type of training proposed. Training may be offered to a wide range of
scientists, including laboratory scientists, clinicians, social scientists, and
other health professionals, as well as technical and administrative staff. The
intent of all training proposed should be to build a critical mass of
researchers and support staff with the combined expertise and skills to conduct
research.

Provide a detailed description of the recruitment and selection
procedures and criteria for the foreign doctoral and post-doctoral scientists
and other beneficiaries of the research training program (short term trainees,
workshop participants, etc). The TAG should be included in this process.
Criteria should include a list of standards that will be used to ensure that
trainees have appropriate prior training and experience, are likely to complete
the program, and are likely to develop into productive independent
researchers. The recruitment and selection process must be transparent
and widely advertised within the appropriate countries.

Degree candidates must meet all entrance requirements of the U.S. or foreign degree-granting institution. Thought should also be given to
preparation of non-degree long-term trainees in English language and/or
computer skills in the summer preceding studies in the U.S. or at the foreign
site, where appropriate, to allow them to make optimal use of their formal
training period. Fees for such courses are allowable costs.

Applicants should describe strategies for recruiting and retaining
women and socially and economically disadvantaged persons as trainees.
Applications must identify a major role of the partner institutions in the
recruitment and selection plan.

This plan should include procedures for retaining students in the research
training program until completion.

Describe strategies to encourage trainees to remain in or return to
their home countries after completion of their training.

Discuss plans to promote diversity relevant to the proposed LMICs,
rather than those defined within the U.S. context. Do not complete Tables
10.

Section 8.9.7 Human Subjects

Applicants should describe plans to meet the requirements related to
the protection of human subjects in all training-related research. All
non-degree training-related research projects in which trainees are involved
under this award must be peer-reviewed through the TAG. It is assumed
that all degree-related research receives peer review through standard
institutional mechanisms. All trainees involved in human subjects research need
documented evidence for education in the protection of human subjects for the
trainee, compliance with the required federal citations, and approval from
institutional (or ethical) review boards or committees at applicant and
collaborating foreign institutions, and from the relevant government
authority.

Follow PHS 398 instructions for

8.9.8 Vertebrate Animals

8.9.9 Select Agent Research

8.9.10 Literature Cited

8.9.11 Multiple PD Leadership Plan

8.9.12 Consortium/Contractual Arrangements

8.9.13 Participating Faculty Biosketches

8.9.14 Data Tables- Attach all Data Tables (1-12B) but complete
only Tables 2 and 4 for all applications and complete Tables 6, 12A and
12B for renewal applications.

6. Other Submission Requirements and Information

Appendix
Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent
due dates must provide
appendix material on CD only, and include five identical CDs in the same
package with the application. Paper applications submitted for due dates
prior to May 25, 2008 may voluntarily provide the appendix on five identical
CDs; if submitting CDs it is not necessary to include a paper appendix. (seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not observe the required page limitations
may be delayed in the review process.

Resource Sharing
Plan(s)

The
following resource sharing policies do not apply to this FOA:

Data
Sharing Plan. Not
Applicable

Sharing
Model Organisms. Not Applicable

Genome Wide Association Studies (GWAS). Not
Applicable

Specific
Instructions for Foreign Applications

All
foreign applicants must complete and submit budget requests using the Research
& Related Budget component found in the application package for this FOA.
See NOT-OD-06-096, August
23, 2006.

Section
V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review
criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs for funding consideration on the basis
of established PHS referral guidelines.

As
part of the scientific peer review, all applications will:

Undergo a
selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score.

Receive a
written critique.

Receive a
second level of review by the FIC Advisory Board.

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:

Scientific
merit of the proposed project as determined by scientific peer review.

The
goals of NIH supported research training are to advance our understanding of
biological systems, to improve the control of disease, and to enhance health.
In their written critiques, reviewers will be asked to comment on each of the
following criteria in order to judge the likelihood that the proposed research
training will have a substantial impact on the pursuit of these goals. Each of
these criteria will be addressed and considered in assigning the overall score,
and weighted as appropriate for each application. Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a meritorious priority score. For example,
an investigator may propose to carry out important work that by its nature is
not innovative but is essential to move a field forward.

Significance: Does this research training program address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of this program on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field?

Are the needs for the proposed
specific chronic disease research training fill the specific gaps in the
research expertise at the LMIC institution(s)?

Will the expected public health
benefits and scientific contributions relate to the proposed chronic
disease research training?

Will the LMIC institution(s) have
the ability to develop a cadre of multidisciplinary (biomedical,
behavioral, epidemiological, social sciences clinical research,
operational, health services, implementation science) chronic disease
researchers at the LMIC institution(s)?

Potentially, will the LMICs
institutions achieve both independent and sustainable laboratory, clinical
and public health research capacity at the LMICs through the proposed
training efforts?

Does the proposed chronic disease
research training strengthen the capacity of LMIC institution(s) over the
life of the grant and provide opportunities for trainees and junior
faculty to rise to scientific leadership positions in this or related
areas?

Approach:Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
For applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs?

Are the
clarity and feasibility of the research training objectives found to be
adequate within the research-training plan in order to achieve the
proposed training objectives?

Does the
breadth of training opportunities provided fall within one of the
following research areas: biomedical, behavioral, social sciences,
clinical research, epidemiological operational, health services, or
implementation science which will provide the ability to develop true
multidisciplinary research teams at the LMIC institution(s)?

Does the
mix of long-, medium- and short-term training achieve the goals of this
FOA, while taking into consideration existing conditions and existing
capacity at the LMICs institution(s)?

Is there
a selection process for trainee recruitment that captures the most
qualified individuals who could most benefit from the training proposed?

Are there
strategies that are culturally sensitive in recruiting an adequate
representation of women, ethnic minorities and socially disadvantaged
groups among the LMIC trainees?

Is there
a process for matching trainees to appropriate mentors or instructors and
research projects or needed research skills to fill recognized gaps in
expertise at the LMIC institution?

What is
the process for scientific peer review of trainee research?

Is there
a plan for training in sustainable research enhancing areas such as
laboratory safety, responsible conduct of research, scientific writing, grant
writing, statistical methods, good clinical practice, medical informatics,
data management, management of intellectual property, and English as a
second language, if necessary?

What is
the process for periodic evaluation of trainee progress in acquiring
academic and research skills?

What are
the approaches to support post-training integration into research at the
LMIC institution(s)?

Is there
a method to evaluate the long-term impact of this research training
program on the subsequent careers of the trainees and the research
capacity at the LMIC institution(s)?

Innovation: Is the project
original and innovative? For example: Does the project challenge existing
paradigms or clinical practice; address an innovative hypothesis or critical
barrier to progress in the field? Does the project develop or employ novel
concepts, approaches, methodologies, tools, or technologies for this
area?

Have
you identified and provided innovative strategies for trainees to become
actively involved in laboratory studies, clinical or public health research
studies relevant to national health priorities conducted at the LMIC
institution(s) through the life of the training plan?

What
are the plans for the leveraging the research infrastructure of the applicant
and other partner or collaborating institutions which include previous and
current investments and support from FIC, other NIH ICs, CDC, USAID or other
organizations (e.g., President’s Emergency Plan for AIDS Relief [PEPFAR],
the Bill and Melinda Gates Foundation, the Global Fund to fight AIDS, TB and
Malaria, or the President’s Malaria Initiative)?

What
innovative training strategies will produce a critical mass of independent
researchers and sustainable research training by trainees at the developing
country institution at the end of the program?

Are
the plans creative in using modern information technology to facilitate trainee
access to scientific information, distance learning and collaborative
interaction?

Investigators:Are the
PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project
(if applicable)?

Are
the program director(s) (including multiple PDs) qualify to lead and are
the U.S. and LMIC faculty qualify to participate as mentors in the
proposed research training program?

Is
the ongoing collaboration between the U.S. and LMIC investigators
adequate? Does their institution provide a suitable framework in which the
proposed training will occur?

What
is the extent and effectiveness of previous research training efforts made
by applicants in the proposed LMICs?

What
is the ability and relevance of the sources of research support of the
program director(s) (including multiple PDs) and faculty to the research
training plan proposed?

How
will the Training Advisory Group be constructed to serve the functions
defined in this FOA?

Environment: Do(es) the scientific environment(s) in which the work will be done
contribute to the probability of success? Does the proposed training benefit from
unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?

Is
the teaching and research facilities adequate? Do(es) other
resources and ongoing research support relate to the overall training
environment at the U.S. and LMICs institutions?

Are
the U.S. and LMIC governmental and institutional commitments to the
proposed chronic disease research training sufficient?

If
multiple foreign sites participate, does the value added of including
multiple sites and the adequacy of communication and coordination plans
integrate the teaching program?

2.A. Additional Review Criteria:

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Resubmission
Applications(formerly
“revised/amended” applicationsAre the responses to comments from the previous
scientific review group adequate? Are the improvements in the resubmission
application appropriate?

Training in Protection of Human Subjects from Research Risk: The
plans for training regarding the involvement of human subjects and protections from research risk relating
to their participation in the proposed trainee research will be assessed (see
the Research Training Plan section on Human Subjects in the PHS 398 instructions).

Training in Inclusion of Women, Minorities and Children in Research: The adequacy of training plans regarding
the inclusion of subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the trainee research will be assessed if
involved in proposed trainee research.

Training in Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be
used in the trainee projects, plans for training in care and use of animals in
research will be assessed.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.

Training
in the Responsible Conduct of Research:

We expect all applicants and key personnel to exhibit
appropriate training in the responsible conduct of research as a just-in-time
requirement.

Programs must have appropriate mechanisms in place to
capture trainee demographic data.

Applications
from Foreign Organizations: Whether the project presents special opportunities
for furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not
readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing
Plan(s)

The
following resource sharing policies do not apply to this FOA:

Data
Sharing Plan. Not
Applicable

Sharing
Model Organisms. Not Applicable

Genome Wide Association Studies (GWAS). Not
Applicable

3. Anticipated
Announcement and Award Dates

Not
Applicable

Section
VI. Award Administration Information

1. Award Notices

After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

A final
progress report, invention statement, and Financial Status Report are required
when an award is relinquished, when a recipient changes institutions or when an
award is terminated.

Section
VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:

Human
Subjects Protection:Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and
Safety Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.

Policy
for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of
Model Organisms:NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of
Women And Minorities in Clinical Research:It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required
Education on the Protection of Human Subject Participants:NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human
Embryonic Stem Cells (hESC):Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research. Applications that do
not provide this information will be returned without review.

NIH Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH
Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.